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Monoclonal Antibodies
Dupilumab for Eosinophilic Gastrointestinal Diseases (ENGAGE Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24 and at week 52
Awards & highlights
ENGAGE Trial Summary
This trial is researching an experimental drug to treat EoG & EoD, two uncommon, persistent, allergic/immune diseases, to reduce symptoms & inflammation in adults & adolescents.
Who is the study for?
Adults and adolescents aged 12+ with active eosinophilic gastritis (EoG), not just duodenitis, can join this trial. They must have a history of EoG symptoms, documented diagnosis, and meet specific symptom severity scores. Exclusions include Helicobacter pylori infection, certain dietary changes before screening, major upcoming surgery, other gastric conditions like Crohn's disease or past dupilumab use.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of an experimental drug called dupilumab in two different doses compared to a placebo for treating EoG with or without EoD. It will also examine how much drug is in the blood over time and if the body creates antibodies against it.See study design
What are the potential side effects?
Potential side effects from taking dupilumab may include allergic reactions, possible development of antibodies that could reduce drug effectiveness or cause additional side effects; detailed side effect profiles will be studied.
ENGAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 24 and at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24 and at week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS)
Proportion of participants achieving a peak gastric eosinophil count of ≤6 eosinophils/high power field (eos/hpf)
Secondary outcome measures
Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)
Absolute change in the EoG/EoD-SQ TSS
Change in frequency of diarrhea epispodes
+21 moreENGAGE Trial Design
3Treatment groups
Experimental Treatment
Group I: Part C: Extended Active Treatment PeriodExperimental Treatment3 Interventions
Eligible participants from Part A and Part B will enter Part C. Part A participants will get Dose 1. Part B participants who received Dose 1 or Dose 2 will remain on Dose 1 or Dose 2. Part B placebo participants will be randomized 1:1 to receive Dose 1 or Dose 2.
Group II: Part B: Phase 3Experimental Treatment3 Interventions
Randomized 1:1:1
Group III: Part A: Phase 2Experimental Treatment2 Interventions
Randomized 1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Matching Placebo
2012
Completed Phase 4
~10710
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
622 Previous Clinical Trials
380,452 Total Patients Enrolled
1 Trials studying Eosinophilic Gastritis
41 Patients Enrolled for Eosinophilic Gastritis
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,701 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
251,135 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My body weight is under 40 kg.I've had at least 2 episodes of gastrointestinal symptoms weekly in the last 8 weeks.I have previously participated in a dupilumab trial or have been treated with dupilumab.I am currently on tube feeding or IV nutrition.I am a teenager and my country allows me to join this study.I have been diagnosed with Helicobacter pylori infection.I have a narrow esophagus that can't be examined with a standard scope without dilation.I was diagnosed with Eosinophilic gastritis through a biopsy at least 3 months ago.I do not have conditions like Churg-Strauss syndrome or hyper-eosinophilic syndrome.I am expecting to undergo a major surgery during the study.My symptom scores have been high for the past 2 weeks.I have a history of specific digestive conditions or surgeries.My biopsy shows I have EoG due to high eosinophil levels.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Phase 3
- Group 2: Part C: Extended Active Treatment Period
- Group 3: Part A: Phase 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical research recruiting participants at present?
"Affirmative. The latest information from clinicaltrials.gov specifies that this research initiative, which began on May 3rd 2023, is currently enrolling patients. A total of 279 participants are needed between two medical centres."
Answered by AI
How many individuals are partaking in the current clinical trial?
"Affirmative. According to information on clinicaltrials.gov, this therapeutic experiment is currently signing up participants and was last updated on May 12th 2023. The trial requires 279 individuals from 2 medical facilities to be recruited."
Answered by AI
To what end is this trial aiming to reach?
"The principal aim of this trial, to be monitored at Week 24, is the alteration in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS). Secondary objectives include measuring changes in peak gastric tissue eosinophil count and peak duodenal tissue eosinophil count across Part A, B, and C for those with duodenal involvement. Lastly, researchers will gauge how many participants achieved a peak duodenal tissue eosinoph"
Answered by AI
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